Thanks to advocates’ endless campaigning and increased clinical attention, endometriosis is finally beginning to receive the attention it deserves. ‘Endo Warriors’ – the adopted name for those suffering from the condition – are pushing hard for better understanding, diagnosis, and treatment. However, while awareness increases, there are still many unanswered questions about the disease, and no solution has been found to address its root cause. European startup FimmCyte hopes to change all this and finally bring relief to those suffering from the debilitating disease. We spoke to the company’s co-founder, Dr Mohaned Shilaih. He tells us what they are developing, how they are collaborating with Ferring Pharmaceuticals through BioInnovation Institute’s (BII) venture program and what he thinks needs to happen next to create real momentum in women’s health.

You spoke with us a few years ago now about your startup, FimmCyte, but can you explain again a little more about how your non-hormonal treatment works? 

FimmCyte is developing a disease-modifying non-hormonal treatment for endometriosis. We’ve taken a very targeted and deliberate approach to the disease. Our idea was to systematically examine what would constitute an ideal endometriosis treatment and then look for ways to deliver it. We know that nearly all women get endometriosis, but only 10% develop the lesions and symptoms. Many factors are at play regarding the cause of endometriosis, but the immune system can quickly clear out these affected tissues in women who don’t get symptoms. For women with symptomatic endometriosis, the body is unable to clear these cells for some reason that is yet to be determined. And that’s where we’ve put our focus. Could we find a signature on the endometriotic cells to encourage the immune system to re-recognize them as bad or unhealthy? My co-founder, Dr Valentina Vongrad, collected many patient samples and looked for targets uniquely expressed in endometriotic cells. We’ve now used these targets to generate an antibody that can label endometriotic cells as sick or diseased. In testing via several animal models, we were incredibly excited to find that the immune system did identify and clear the ‘bad’ cells as hoped. The significant advantage is that it’s non-hormonal therapy, so it’s compatible with fertility, and it’s much less invasive than hormones and surgery.  

It sounds hugely promising, and many people will anxiously monitor how the treatment develops. What are the next steps for FimmCyte? 

Drug development is a long and complex journey. We joined BII’s Venture Lab Program in 2022. We have advanced from the prototype to the clinical candidate stage in the past couple of years. Our focus has been confirming the treatment is safe and effective. The exciting thing is that there is potential that the molecule could advance to patients quickly with enough funding. We’re now in BII’s Venture House cohort, extending our strategic collaboration with Ferring Pharmaceuticals under the Reproductive Medicine and Maternal Health track.  

You’ve come a long way in a (relatively) short time in drug development. Alongside BII, what role has Ferring played in your organization? Where would you be if the company were not involved? 

You can rarely have such close interaction with a pharmaceutical company at such an early stage. It’s been hugely validating and a significant boost. If a company like Ferring is happy to associate its name with yours, it’s a big positive signal to other stakeholders. In biotech and therapeutics, people want to see that someone has trusted them to deliver on promises and that the data supports what they claim. But of course, the partnership brings even more benefits. Ferring provides us access to a highly experienced team that is well-versed in the disease area and, most importantly, has an open mind. Because they are proactively engaged, it’s a sign to us that they believe in our program. The close collaboration with Ferring gave us the ability to validate work packages with highly experienced drug developers before we executed them, reducing the probability of making trivial mistakes. It also provided invaluable insights into the market and commercial aspects that are otherwise very hard or costly to generate. These inputs have been a speed booster and a cost reducer for FimmCyte. We’ve also learned directly about the expectations of pharmaceutical companies. It has been helpful to get that perspective firsthand. We’ve been able to ask and answer: what does the pharma industry want, and what would that look like? 

Women’s health is notoriously under-researched and underfunded. How are you finding the fundraising? 

We’re an experienced team with plenty of industry experience, with meticulous planning and risk mitigations we can confidently overcome technical limitations. But the market and business side are different. Funding is always tough in this space. We’ve had to convince people that our idea is exceptional while going against the current market trend in endometriosis, which has been going down rather than up for the past twenty years. For many decades, the incumbents have been hormonal therapies. We’re a disruptor, and unfamiliarity is nerve-wracking for all stakeholders. They have nothing to benchmark against.

For the millions of women desperately needing your treatment, let’s hope more investors get on board soon. Funding is one of many challenges faced by those innovating in this space. How are you feeling about the future of endometriosis care and women’s health? 

The challenge with endometriosis is that there isn’t enough basic research to address its diversity and complexity. We need more investment so that we can increase the number of shots on target for endometriosis drug development. For example, in other disease areas, huge consortiums pool their samples, data, and materials. They create strength in numbers, but you may be surprised to learn that this only just starting in endometriosis. But regarding women’s health, we’re heading in the right direction. High-quality, highly experienced researchers and entrepreneurs will start taking on more women’s health projects. That way, they can enrich the ecosystem with their knowledge. But we also need people to do more and say less. Sometimes, when you work in women’s health, it feels like you’re in a packed stadium, but there are no players on the pitch. There are plenty of people cheering, but no one is playing. The market can sound busy, but the reality is that it is counterproductive. For example, if you look at how many potential endometrioses drug candidates are in a pre-clinical database, you’ll find hundreds. But only two to three of those are viable. We need smartly allocated funds in the right place and high-quality translational research, and then things will change. 

The BioInnovation Institute’s (BII) Venture Lab program provides startups with funding, a dedicated anchor, leadership coaching, plus lots more. The program is designed for early-stage startups or researchers who have not yet established a startup. The Venture Lab program – including The Reproductive Medicine and Maternal Health Track jointly supported by Ferring Pharmaceuticals – is currently open for applications. Apply here no later than January 29th, 2025.